Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Lupus Nephritis
Interventions
DRUG

Mycophenolate sodium

Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.

DRUG

Prednisone

Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.

DRUG

Methylprednisolone

All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.

Trial Locations (17)

Unknown

Novartis, Bogotá

Novartis, Créteil

Novartis, Nantes

Novartis Investigative Site, Paris

Novartis, Berlin

Novartis, Tübingen

Novartis, Athens

Novartis, Budapest

Novartis, Debrecen

Novartis, Brescia

Novartis, Ferrara

Novartis, Milan

Novartis, Padua

Novartis, Barcelona

Novartis, Madrid

Novartis, Taichung

Novartis, Cambridge

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY